RecruitingNot ApplicableNCT07115953

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension

Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)


Sponsor

Medtronic Vascular

Enrollment

130 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a procedure called renal denervation — where a catheter is used to disrupt the overactive nerves around the kidney arteries — as a treatment for high blood pressure that is not controlled with medications. **You may be eligible if...** - You have been diagnosed with high blood pressure - Your blood pressure remains high despite treatment: office systolic ≥140 mmHg, diastolic ≥90 mmHg, and home systolic average ≥135 mmHg - You are able to complete a 24-hour blood pressure monitoring test **You may NOT be eligible if...** - Your kidney arteries are not suitable for the procedure - You have previously had renal denervation - Your kidney function is significantly reduced (eGFR below 45) - You have episodes of orthostatic hypotension (blood pressure dropping when you stand) - You are pregnant or planning to become pregnant - You have type 1 diabetes or poorly controlled type 2 diabetes (HbA1c over 8%) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESymplicity Spyral™ multi-electrode renal denervation system

After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.


Locations(19)

The Alfred Hospital

Melbourne, Australia

Royal Perth Hospital

Perth, Australia

Ziekenhuis Oost Limburg - Campus Sint-Jan

Genk, Limburg, Belgium

CHC MontLégia

Liège, Liège, Belgium

Algemeen Stedelijk Ziekenhuis - Campus Aalst

Aalst, Belgium

AZ Sint Jan Brugge-Oostende av

Bruges, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitat des Saarlandes

Homburg, Saarland, Germany

Sana Kliniken Lübeck GmbH

Lübeck, Schleswig-Holstein, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Leipzig Heart Institute

Leipzig, Germany

Schwarzwald-Baar Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

Mater Misericordiae University Hospital

Dublin, Dublin, Ireland

Sarawak Heart Center

Kota, Malaysia

Zuyderland Medisch Centrum Heerlen

Heerlen, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

MacKay Memorial Hospital, Tamsui Branch

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Oxford University Hospitals NHS Trust - John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07115953


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